Abstract
Disposable equipment has been used for many years in the downstream processing industry, but mainly for filtration and buffer/media storage. Over the last decade, there has been increasing interest in the use of disposable concepts for chromatography, replacing steel and glass fixed systems with disposable plastic modules that can be discarded once exhausted, fouled or contaminated. These modules save on cleaning and validation costs, and their reduce footprints reduce buffer consumption, water for injection, labor and facility space, contributing to an overall reduction in expenditure that lowers the cost of goods. This chapter examines the practical and economic benefits of disposable modules in downstream processing.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Abbreviations
- BSA:
-
Bovine serum albumin
- cGMP:
-
Current good manufacturing practice
- CIP:
-
Cleaning in place
- DNA:
-
Deoxyribonucleic acid
- LRV:
-
Log reduction value
- MuLV:
-
Murine leukemia virus
- MVM:
-
Minute virus of mice
- PRV:
-
Pseudorabies Virus
- SIP:
-
Steaming in place
References
Sinclair A, Monge M (2004) BioProcess Int 2:26
Meyeroltmanns F, Schmitz J, Nazlee M (2005) BioProcess Int 3:60
Walter JK (1998) In: Subramanian G (ed.) Bioseparation and bioprocessing. processing, quality and characterization, economics, safety and hygiene. Wiley-VCH, p 447
Ransohoff T (2004) Poster Presentation at BPD North Carolina Biotechnology Center
Gottschalk U (2006) Biopharm Int 19(Suppl):8
Muller-Spath T, Morbidelli M (2009) In: Gottschalk U (ed.) Downstream processing of antibodies. Wiley, New York (in press)
Kelley B (2007) Biotechnology Prog 23:995
Low D, O’Leary R, Pujar NS (2007) J Chromatogr B 848:48
European Commission Enterprise Directorate General (2001) Working party on control of medicines and inspections. EU guide to good manufacturing practice, vol. 4, Annex 15, July 2001, Cleaning Validation
FDA (2004) Equipment cleaning and maintenance. Code of Federal Regulations (CFR) Part 211.67 Title 21 Rev. FDA, Rockville MD
FDA (2006) Guide to inspections validation of cleaning processes. FDA, Rockville MD
Gottschalk U (2005) BioPharm Int 18:24
Mora J, Sinclair A, Delmdahl N, Gottschalk U (2006) Bioprocess Int 4(Suppl):38
CPMP (1996) Note for guidance on virus validation studies. The design, continuation and interpretation of studies validating the inactivation and removal of viruses. CPMP/BWP/268/95
Immelmann A, Kellings K, Stamm O, Tarrach K (2005) Bioprocess Int 3:38
DiBlasi K, Jornitz MW, Gottschalk U, Priebe PM (2006) The BioPharm Int (suppl) 19:6
Gottschalk U (2008) Biotechnol Prog 24:496
Prashad M, Tarrach K (2006) FISE 9:28
Tarrach K, Köhler K, Grimm C (2008) Pharma Tech Eur 20:1
Curling J, Gottschalk U (2007) BioPharm Intl 20:70
Gebauer K, Thommes J, Kula M (1997) Biotechnol Bioeng 54:181
Gottschalk U, Lamproye A, Zhou J, Sinclair A, Reif O-W (2006) Poster Presentation at Recovery of Biological Products XII
Zhou J (2006) IBC Technology Transfer for Biopharmaceuticals
Sinclair A, Monge M (2002) Pharma Eng 22:20
Lim JAC, Sinclair A, Kim DS, Gottschalk U (2007) BioProcess Intl 5:60
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2009 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
Gottschalk, U. (2009). Disposables in Downstream Processing. In: Eibl, R., Eibl, D. (eds) Disposable Bioreactors. Advances in Biochemical Engineering / Biotechnology, vol 115. Springer, Berlin, Heidelberg. https://doi.org/10.1007/10_2008_22
Download citation
DOI: https://doi.org/10.1007/10_2008_22
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-01871-8
Online ISBN: 978-3-642-01872-5
eBook Packages: Chemistry and Materials ScienceChemistry and Material Science (R0)